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Publication bias in studies on biologic therapy for children with inflammatory bowel disease
Ariel Weil1, Gili Focht1, Ohad Atia1
1Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition, Eisenberg R&D Authority, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel.
Insights
Positive results from biologic drug studies in pediatric inflammatory bowel disease (IBD) are more likely to be published. This highlights potential publication bias in evidence-based treatment strategies for pediatric IBD.
Area of Science:
- Pediatric Gastroenterology
- Clinical Research
- Biologic Therapies
Background:
- Biologic drug use in pediatric inflammatory bowel disease (IBD) has increased significantly.
- This surge follows positive findings from clinical trials and real-world evidence.
- Assessing publication bias in these studies is crucial for accurate interpretation.
Purpose of the Study:
- To investigate the extent of publication bias in studies on biologic drugs for pediatric IBD.
- To analyze factors influencing the publication of research presented at major pediatric gastroenterology conferences.
Main Methods:
- Two reviewers evaluated abstracts on biologic efficacy/safety from 2015-2019 conferences.
- Abstracts were categorized as positive or negative regarding treatment outcomes.
- Time to publication was analyzed using survival analysis (Kaplan-Meier curves and Cox models).
Main Results:
- Only 62% of 209 abstracts were published as full manuscripts.
- Positive results were associated with a significantly higher likelihood and earlier publication (HR=4.4, OR=6.4).
- Publication probability at 5 years was 66% for positive abstracts vs. 25% for negative ones (p<0.001).
Conclusions:
- A substantial proportion of pediatric IBD biologic research abstracts remain unpublished.
- Studies with positive outcomes are more likely to be published, indicating potential publication bias.
- Awareness of this bias is essential for clinicians and regulatory bodies when forming evidence-based guidelines.
Objective:
The utilization of biologic drugs in children with inflammatory bowel disease (IBD) surged following the publications of positive results in randomized controlled trials and real-world studies. We aimed to explore the extent of publication bias associated with these findings.
Methods:
Two reviewers assessed all abstracts evaluating the efficacy or safety of biologics presented at the annual European Society for Pediatric Gastroenterology Hepatology and Nutrition and North American Society for Pediatric Gastroenterology conferences from 2015 to 2019. Abstracts were classified as "positive" or "negative." Time to publication was analyzed using Kaplan-Meier curve and groups were compared using the log-rank test. A Cox proportional model was utilized to determine the likelihood of publication.
Results:
Out of 209 included abstracts, only 130 (62%) were published as full manuscripts. The median time to publication was 2.8 years (interquartile range = 0-8.2). In the univariate Cox model, the likelihood of publication was four times higher for abstracts reporting positive results (hazard ratio = 4.4 [95% confidence interval, CI = 2.3-8.5]). The probabilities for publication at 1, 3, and 5 years after the conference were 32%, 59%, and 66% for abstracts with significantly positive results in favor of biologic treatment compared to 10%, 22%, and 25% for those with negative results (p < 0.001). In multivariable model, positive results (odds ratio = 6.4 [95% CI = 2.5-16.4]) were significant associated with publication rate.
Conclusion:
Only 62% of abstracts presented in medical conferences regarding biologics in pediatric IBD are eventually published as full manuscripts, and those reporting positive results were more likely to be published and at an earlier time. Clinicians, guideline groups, and medical authorities dealing with drug approval, need to be aware of potential publication bias of published studies when employing evidence-based management strategies.
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